A Formal Methods Approach to Medical Device Review

Authors:
Raoul Jetley;S. Purushothaman Iyer;Paul L. Jones
Affiliations:
North Carolina State University;North Carolina State University;US Food and Drug Administration, Center for Devices and Radiological Health
Venue:
Computer
Year:
2006

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Abstract

As device software becomes more complex, regulators need rigorous evaluation tools and methods to assure safe operation of this software. The research presented here applies formal methods-based techniques to this problem space.